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MOVICOL LIQUID ORANGE FLAVOUR CONCENTRATE FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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Package Leaflet: Information for the patient

MOVICOL

®

Liquid Orange flavour
Concentrate for oral solution
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you
feel worse.
If you need the information on this leaflet to be supplied
in an alternative format, such as large print or Braille,
please ring from the UK: 0800 198 5000.
What is in this leaflet:
1. What Movicol Liquid Orange flavour is and what it is used for
2. What you need to know before you take Movicol Liquid
Orange flavour
3. How to take Movicol Liquid Orange flavour
4. Possible side effects
5. How to store Movicol Liquid Orange flavour
6. Contents of the pack and other information

1. What Movicol Liquid Orange flavour is and what it
is used for

The name of this medicine is Movicol liquid Orange flavour
concentrate for oral solution.
It is a laxative for the treatment of chronic constipation in adults,
adolescents and elderly. It is not recommended for children below
12 years of age.
Movicol liquid Orange flavour helps you to have a comfortable
bowel movement even if you have been constipated for a long time.
You must not use Movicol liquid Orange flavour if you have a very
bad constipation called faecal impaction

2. What you need to know before you take Movicol Liquid
Orange flavour
Do not take Movicol Liquid Orange flavour if your doctor
has told you that you have:
- a blockage in your intestine (gut obstruction, ileus)
- a perforated gut wall
- severe inflammatory bowel disease like ulcerative colitis, Crohn’s
disease or toxic megacolon
- an allergy to the active substances or any of the other
ingredients of Movicol liquid Orange flavour (listed in section 6).
Warnings and precautions
When taking Movicol Liquid Orange you should continue to take
plenty of fluids. The fluid content of Movicol should not replace your
regular liquid intake.

Other medicines and Movicol Liquid Orange flavour
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines, e.g. anti-epileptics, (medicines for epilepsy) may not
work as effectively during use with Movicol liquid Orange flavour.
Pregnancy and breast-feeding
Movicol liquid Orange flavour can be taken during pregnancy and
whilst breast feeding. If you are pregnant, trying to become
pregnant or breast feeding, ask your pharmacist or doctor for
advice before taking Movicol liquid Orange flavour.
Driving and using machines
Movicol liquid Orange flavour does not affect your ability to drive
or use machines.
Important information about some of the ingredients of
Movicol liquid Orange flavour
This medicinal product contains ethyl and methyl
parahydroxybenzoate which may cause allergic reactions,
possibly delayed.
It also contains:
• small amounts of ethanol (alcohol), less than 100 mg per
25 ml dose.
• 45.6 mg of benzyl alcohol in each diluted dose of 125 ml.
Do not exceed the stated dose.

3. How to take Movicol Liquid Orange flavour
This medicine can be taken at any time with or
without food.

This product must be diluted before use.

A dose of Movicol liquid Orange flavour is 25 ml liquid diluted in
100 ml of water.
Take this 1–3 times a day according to the severity of your
constipation.
How to mix:
Open the bottle and measure 25 ml or five 5 ml teaspoonfuls.
Pour the liquid into a glass and then add 100ml (about half a
glassful) of water. Stir well until all the liquid has been evenly
mixed and the diluted Movicol liquid Orange flavour solution is
clear, then drink it.
Please rinse the dosing cup after use and replace on the bottle.
Duration of treatment:
Treatment with Movicol liquid Orange flavour usually lasts for
about 2 weeks. If you need to take Movicol liquid Orange flavour
for longer, please see your doctor. If your constipation is caused by
an illness such as Parkinson’s disease or multiple sclerosis (MS), or
if you take medicines that cause constipation your doctor may
recommend that you take Movicol liquid Orange flavour for longer
than 2 weeks.
Usually for long term treatment the dose can be lowered to either
1 or 2 doses a day.
If you take more Movicol liquid Orange flavour than you should
You may develop excessive diarrhoea, which can lead to
dehydration. If this occurs, stop taking Movicol liquid Orange
flavour and drink plenty of fluids. If you are worried contact your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects although
not everybody gets them.
If you have a serious allergic reaction which causes difficulty in
breathing, or swelling of the face, lips, tongue or throat, tell your
doctor immediately and stop taking Movicol liquid Orange flavour.
Other allergic reactions may occur which may cause a skin rash,
itching, reddening of the skin or a nettle rash, swollen hands, feet
or ankles and headache.
Other side effects may also include indigestion, stomach ache
or rumbles and high and low levels of potassium in the blood.
You may also feel bloated, suffer from wind, feel sick or vomit,
may also experience soreness of the anus (bottom) and may have
mild diarrhoea when starting to take Movicol liquid Orange flavour
which generally gets better if you reduce the amount of Movicol
liquid Orange flavour you take.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

5. How to store Movicol Liquid Orange Flavour
Keep this medicine out of the sight and reach of children.
Do not use Movicol liquid Orange flavour after the expiry date
which is stated on the bottle. The expiry date refers to the last day
of that month.
Do not refrigerate or freeze.
Discard any remaining product 30 days after first opening
the bottle.
Once you have diluted Movicol liquid Orange flavour in water, if
you cannot drink it straight away keep it covered. Throw away any
solution not used within a 24 hour period.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Movicol liquid Orange flavour contains
Each 25 ml of Movicol liquid Orange flavour contains
the following:
Macrogol 3350
13.125 g
Sodium Chloride
0.3507 g
Sodium Hydrogen Carbonate
0.1785 g
Potassium Chloride
0.0466 g
Movicol liquid Orange flavour also contains purified water, orange
flavour, and acesulfame potassium (E950) and sucralose (E955) as
sweeteners.
It also contains a preservative which contains benzyl alcohol,
methyl parahydroxybenzoate (E218) and ethyl

parahydroxybenzoate (E214).
Orange flavour contains the following ingredients: flavouring
substances, flavouring preparations and ethanol (alcohol).
When each 25 ml is made into a drink with 100 millilitres of water,
it gives the equivalent of:
Sodium
65 millimoles/litre
Chloride
53 millimoles/litre
Potassium
5.4 millimoles/litre
Hydrogen Carbonate
17 millimoles/litre
Movicol liquid Orange flavour contains 8.125 mmol of sodium in
each diluted dose of 125 ml. To be taken into consideration by
patients on a controlled sodium diet.
What Movicol liquid Orange flavour looks like and contents
of the pack
Movicol Liquid Orange flavour is a clear, colourless liquid.
Each pack consists of a carton with a plastic bottle of Movicol
liquid Orange flavour containing 500 ml of solution and a plastic
dosing cup.
Marketing Authorisation Holder
Norgine Pharmaceuticals Limited,
Widewater place, Moorhall Road,
Harefield, Middlesex UB9 6NS, UK
Manufacturer:
Norgine Pharma Dreux, 29, Rue Ethé Virton,
28109 Dreux Cedex, France
or
Norgine Limited, New Road, Hengoed,
Mid Glamorgan, CF82 8SJ, UK.
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria MOVICOL® Liquid Orange
Belgium MOVICOL® Vloeibaar Sinaasappelsmaak
MOVICOL® Liquide Goût orange
MOVICOL® Flüssig Orangengeschmack
Germany
Macrogol Norgine Orangengeschmack
Konzentrat zur Herstellung einer Lösung
zum Einnehmen
Finland MOVICOL® Appelsiini
Ireland MOVICOL® Liquid Orange flavour
Italy MOVICOL® 13,9 g/25 ml concentrato per

soluzione orale, gusto Arancio
Luxembourg MOVICOL® Liquide Goût orange
Netherlands MOVICOLON® Liquid Orange
Portugal MOVICOL® Laranja
Spain MOVICOL® Sabor Naranja Solución

/Concentrado para solución oral
Sweden MOVICOL® Apelsin
Switzerland MOVICOL® Liquid Orange
United Kingdom
MOVICOL® Liquid Orange flavour
This leaflet was last revised in 12/2015
NORGINE and the sail logo are regis­tered trademarks of the
Norgine group of companies.

10046204

If you forget to take Movicol liquid Orange flavour
Take the dose as soon as you remember to take it.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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